Robert T. McCormack

TL;DR: Methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers,clinical trialists, the US Food & Drug Administration and the US National Cancer Institute are described.

TL;DR: The CTC0 and CTC conversion end points are robust and meaningful response end points for early-phase metastatic castration-resistant prostate cancer clinical trials and have the highest discriminatory power for overall survival.

TL;DR: A 30% CTC decline after treatment from an initial count ≥5 cells/7.5 ml is independently associated with CRPC overall survival following abiraterone and chemotherapy, improving the performance of a multivariable model as early as 4 wk after treatment.

TL;DR: Recommendations are offered designed to serve as a roadmap to break this vicious cycle of undervaluation and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders.

TL;DR: Using standard definition of CTC conversion, the biomarker panel demonstrated a level of surrogacy for OS by correlating well with survival and in a model-adjusted analysis dramatically attenuating the treatment effect.